What is the most important information to know about prescription TASIGNA?

TASIGNA can cause QT prolongation, a possible life-threatening heart problem. QT prolongation causes an irregular heartbeat, which may lead to sudden death. Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation.

Your doctor should check your heart with a test called an electrocardiogram (ECG):

Before starting TASIGNA

7 days after starting TASIGNA

With any dose changes

Regularly during TASIGNA treatment

Do not take TASIGNA if you have long QTc syndrome or low levels of potassium or magnesium in your blood

TASIGNA can interact with many medicines and supplements. This may increase your chance for serious and life-threatening side effects. Do not take any other medicine while taking TASIGNA unless your doctor tells you it is okay to do so

Food and grapefruit products increase the amount of TASIGNA in your body. This may increase your chance for serious and life-threatening side effects. Take TASIGNA on an empty stomach. Avoid eating food for at least 2 hours before the dose is taken, and avoid eating food for at least 1 hour after the dose is taken. Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA

TASIGNA® (nilotinib) Indications

TASIGNA is a prescription medicine used to treat adults who have:

Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (cytogenetic and molecular).

Ph+ CML in chronic phase and accelerated phase who are no longer benefiting from, or did not tolerate, other treatment including GLEEVEC® (imatinib mesylate). The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (hematologic and cytogenetic)

IMPORTANT SAFETY INFORMATION ABOUT TASIGNA® (nilotinib) Capsules

What is the most important information to know about prescription TASIGNA?

TASIGNA can cause QT prolongation, a possible life-threatening heart problem. QT prolongation causes an irregular heartbeat, which may lead to sudden death. Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation.

Your doctor should check your heart with a test called an electrocardiogram (ECG):

Before starting TASIGNA

7 days after starting TASIGNA

With any dose changes

Regularly during TASIGNA treatment

Do not take TASIGNA if you have long QTc syndrome or low levels of potassium or magnesium in your blood

TASIGNA can interact with many medicines and supplements. This may increase your chance for serious and life-threatening side effects. Do not take any other medicine while taking TASIGNA unless your doctor tells you it is okay to do so

Food and grapefruit products increase the amount of TASIGNA in your body. This may increase your chance for serious and life-threatening side effects. Take TASIGNA on an empty stomach. Avoid eating food for at least 2 hours before the dose is taken, and avoid eating food for at least 1 hour after the dose is taken. Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA

Before taking TASIGNA, tell your doctor about all of your medical conditions, including if you:

Have a heart disorder or are taking medication for the heart

Have had a stroke or other problems due to decreased blood flow to the brain

Have problems with decreased blood flow to your legs

Have an irregular heartbeat

Have QT prolongation or a family history of it

Have liver problems

Know that you suffer from low blood levels of electrolytes, such as potassium or magnesium

Have had a pancreas disorder known as pancreatitis

Have had a surgical procedure involving the removal of the entire stomach (total gastrectomy)

Are lactose-intolerant. The TASIGNA capsules contain lactose. Most patients who have mild or moderate lactose intolerance can take TASIGNA

Have bleeding problems

Are pregnant or plan to become pregnant. TASIGNA may harm your unborn baby. Women should not become pregnant while taking TASIGNA. Talk to your health care provider right away if you are pregnant or plan to become pregnant

Are breastfeeding or plan to breastfeed. It is not known if TASIGNA passes into your breast milk. You and your doctor should decide if you will take TASIGNA or breastfeed. You should not do both

QT prolongation: Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation, a possible life-threatening heart problem

Decreased blood flow to the leg, heart, or brain: People who have recently been diagnosed with Ph+ CML and take TASIGNA may develop decreased blood flow to the leg, the heart, or brain. Get medical help right away if you suddenly develop any of the following symptoms:

Chest pain or discomfort

Numbness or weakness

Problems walking or speaking

Leg pain

Your leg feels cold

Change in the skin color of your leg

Liver damage: Symptoms include yellow skin and eyes

Pancreas inflammation (pancreatitis): Symptoms include sudden stomach area pain with nausea and vomiting

Bleeding in the brain: Symptoms include sudden headache, changes in your eyesight, not being aware of what is going on around you and becoming unconscious

Tumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have:

Kidney failure and the need for dialysis treatment

An abnormal heart beat

Your doctor may do blood tests to check you for TLS

Bleeding: Call your doctor right away if you develop signs and symptoms of bleeding

Most patients experience side effects at some time. Some common side effects you may experience include:

Low blood count

Nausea

Rash

Headache

Tiredness

Itching

Vomiting

Diarrhea

Cough

Constipation

Muscle and joint pain

Runny or stuffy nose, sneezing, sore throat

Fever

Night sweats

Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of TASIGNA. For more information, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Take TASIGNA exactly as your doctor tells you to take it. Do not change your dose or stop taking TASIGNA unless your doctor tells you

TASIGNA is a long-term treatment

Your doctor may change your dose. Your doctor may have you stop TASIGNA for some time or lower your dose if you have side effects with it

If you need to take antacids (medicines to treat heartburn) do not take them at the same time that you take TASIGNA. If you take:

A medicine to block the amount of acid produced in the stomach (H2 blocker): Take these medicines about 10 hours before you take TASIGNA, or about 2 hours after you take TASIGNA

An antacid that contains aluminum hydroxide, magnesium hydroxide, and simethicone to reduce the amount of acid in the stomach: Take these medicines about 2 hours before or about 2 hours after you take TASIGNA